ChiCTR2600124258 版本V1.0 版本创建时间2026/05/09 11:52:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600124258 

最近更新日期：

Date of Last Refreshed on：

 2026-05-09 11:51:51 

注册时间：

Date of Registration：

 2026-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

索凡替尼联合奥曲肽微球在手术不可切除或转移性神经内分泌肿瘤一线治疗的Ⅱ 期、单臂、单中心临床研究

Public title：

Surufatinib Combined with Octreotide Microspheres as First-Line Therapy in Surgically Unresectable or Metastatic Neuroendocrine Tumors: A Phase II, Single-Arm, Single-Center Clinical Study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

索凡替尼联合奥曲肽微球在手术不可切除或转移性神经内分泌肿瘤一线治疗的Ⅱ 期、单臂、单中心临床研究

Scientific title：

Surufatinib Combined with Octreotide Microspheres as First-Line Therapy in Surgically Unresectable or Metastatic Neuroendocrine Tumors: A Phase II, Single-Arm, Single-Center Clinical Study.

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

朱栋元 

研究负责人：

朱栋元 

Applicant：

Dongyuan Zhu 

Study leader：

Dongyuan Zhu 

申请注册联系人电话：

Applicant telephone：

 +86 531 67626279

研究负责人电话：

Study leader's
telephone：

+86 531 67626279

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 405683898@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 405683898@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

济南市槐荫区济兖路440号

研究负责人通讯地址：

山东省济南市槐荫区济兖路440号

Applicant address：

440 Jiyan Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

山东第一医科大学附属肿瘤医院

Applicant's institution：

Shandong First Medical University Affiliated Cancer Hospital

研究负责人所在单位：

山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）

Affiliation of the Leader：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 SDZLEC2026-014-002

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

山东第一医科大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-07 00:00:00

伦理委员会联系人：

李朝伟

Contact Name of the ethic committee：

Li Chaowei

伦理委员会联系地址：

山东省济南市槐荫区济兖路440号

Contact Address of the ethic committee：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 67627162

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 sdzlllh803@126.com

研究实施负责（组长）单位：

山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）

Primary sponsor：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）

具体地址：

山东省济南市槐荫区济兖路440号

Institution
hospital：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

Address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected research topic (self-funded)

研究疾病：

手术不可切除或转移性神经内分泌肿瘤  

Target disease：

Metastatic or surgically unresectable neuroendocrine tumors

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索索凡替尼联合奥曲肽微球在手术不可切除或转移性神经内分泌肿瘤患者一线治疗的疗效和安全性  

Objectives of Study：

To explore the efficacy and safety of surufatinib combined with octreotide microspheres in the first-line treatment of patients with surgically unresectable or metastatic neuroendocrine tumors.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄：≥18岁；
2.经组织学或细胞学证实为神经内分泌瘤患者（G1-3），手术不可切除或存在远处转移，具有可测量病灶（满足 RECIST 1.1 标 准），只有1个可测量的淋巴结病灶除外；
3.既往未接受晚期疾病全身化疗、靶向及内分泌治疗（接受手术或 化疗、靶向、免疫治疗后疾病复发，时间>12个月者允许入组）；
4.ECOG 评分0-1分，预计生存期≥3 月；患者具有全身治疗指征，且无禁忌症；
5.患者能够理解并签署知情同意书（受试者无行为能力时，由其法定代理人代签。

Inclusion criteria

1. Age >=18 years; 2. Patients histologically or cytologically confirmed as having neuroendocrine tumors (G1-3), who are either surgically unresectable or have distant metastasis, and have measurable lesions (meeting RECIST 1.1 criteria), with the exception of having only one measurable lymph node lesion. 3. Patients who have not received prior systemic chemotherapy, targeted therapy, or endocrine therapy for advanced disease (except for those with disease recurrence more than 12 months after prior surgery, chemotherapy, targeted therapy, or immunotherapy, who are eligible for enrollment). 4. ECOG performance status 0-1, with an expected survival of >=3 months; patients must have an indication for systemic treatment and no contraindications to such treatment. 5. The patient is able to understand and provide written informed consent (if the patient lacks the capacity to consent, the consent must be provided by their legally authorized representative).

排除标准：

1.病理诊断为神经内分泌癌患者，包括类癌、不典型类癌、小细胞肺癌等。 2.接受过其他抗血管生成TKI药物和/或奥曲肽治疗，或入组前4周内接受过已获批的或在研的系统抗肿瘤治疗，包括：化疗、根治性放 疗、生物免疫治疗、靶向治疗、中药治疗（说明书有明确抗肿瘤适应 症的中药治疗，经过1周洗脱期也可入组）等； 3.入组前4周内参加过其它国内尚未获批或未上市的药物临床试验且接受了相应试验药物治疗； 4.入组前4周内接受过任何较大手术或较大有创的治疗或操作（静脉置管、穿刺引流等除外），根据研究的判断； 5.受试者既往或同时患有其它恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）； 6.给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系 统性全身治疗； 7.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、 糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例 如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质 激素等）不视为全身性治疗； 8.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑 制疗法；注：允许使用生理剂量的糖皮质激素（≤10mg/天的泼尼松 或等效药物）； 9.已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 10.已知对本研究药物索凡替尼、奥曲肽微球活性成分或辅料过敏者; 11.已知活动性中枢神经系统（CNS）转移和/或癌性脑膜炎、软脑膜排除标准病、癌性脑膜炎患者； 12.已知存在的遗传性或获得性出血及血栓倾向（如血友病人，凝血机能障碍，血小板减少，脾功能亢进等）或近6个月（至首次用药）发生过 动、静脉血栓事件，正在接受溶栓或抗凝治疗； 13.已知人类免疫缺陷病毒（HIV）感染史（即HIV1/2抗体阳性）； 未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数 大于所在研究中心检验科正常值上限）； 14.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）； 15.首次给药之前（第1周期，第1天）30天内接种过活疫苗； 注：允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫 苗；但是不允许接受鼻内用药的减毒活流感疫苗。 16.妊娠或哺乳期妇女； 17.存在任何严重或不能控制的全身性疾病，例如：静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性 左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； 不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2级的慢性心衰；在入选治疗前6个月内发生过任何动脉血栓、栓塞或 缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发 作等；血压控制不理想（收缩压＞140mmHg，舒张压＞90mmHg）；首 次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当 前存在临床活动性间质性肺病；活动性肺结核；存在需要全身性治疗 的活动性或未能控制的感染；严重皮炎、口腔黏膜炎；存在活动性消 化道溃疡、未愈合的胃肠穿孔或消化道瘘患者、临床活动性憩室炎、 腹腔脓肿、胃肠道梗阻、溃疡性结肠炎等严重消化道疾病；肝脏疾病 如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；糖尿病控制不佳 （空腹血糖（FBG）＞10mmol/L）；尿常规提示尿蛋白≥++，且证实 24小时尿蛋白定量＞1.0g者；存在精神障碍且无法配合治疗的患者；研究者判断有临床意义的电解质异常。 18.经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如其他的严重疾病需要合并治疗，有严重的实验室检查异常，伴 有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。 19.入组前14天内接受过输血治疗、血液制品及造血因子，如白蛋白和粒细胞集落刺激因子（G-CSF）等； 20.入组前60天内接受近距离放射疗法（放射粒子植入）。

Exclusion criteria：

1. Patients with a pathological diagnosis of neuroendocrine carcinoma, including but not limited to carcinoid tumor, atypical carcinoid, small cell lung cancer, etc. 2. Have received prior treatment with other anti-angiogenic TKI drugs and/or octreotide; or have undergone any approved or investigational systemic anti-tumor therapies within 4 weeks prior to enrollment, including but not limited to: chemotherapy, radical radiotherapy, biotherapy/immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
(Note: Patients who have received traditional Chinese medicine with explicitly approved anti-tumor indications may still be eligible after a 1-week washout period.); 3. Have participated in another clinical trial of drug(s) not yet approved or marketed in China within 4 weeks prior to enrollment and have received the corresponding experimental drug treatment. 4. Have undergone any major surgery or significant invasive procedure (excluding minor procedures such as venous catheter placement and puncture drainage) within 4 weeks prior to enrollment, in the judgment of the investigator. 5. Patients with a history of or concurrent other malignancies, with the exception of cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. 6. Have received systemic treatment with traditional Chinese patent medicines with approved anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks prior to dosing, with the exception of local use for the control of pleural effusion. 7. Have a history of active autoimmune disease that required systemic therapy (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered a form of systemic therapy. 8. Are receiving systemic corticosteroid therapy (excluding topical administration via routes such as intranasal, inhaled, or other local applications) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. Note: The use of physiologic doses of corticosteroids (e.g., ≤10 mg/day of prednisone or equivalent) is permitted. 9. Have undergone allogeneic organ transplant (with the exception of corneal transplant) or allogeneic hematopoietic stem cell transplant. 10. Have a known history of hypersensitivity to Surufatinib, or to the active ingredients or excipients of Octreotide microspheres. 11. Have a known history of active central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal disease). 12. Have a known history of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism) OR have experienced arterial or venous thrombotic events within 6 months prior to the first dose, or are currently receiving thrombolytic or anticoagulant therapy. 13. Have a known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV-1/2 antibodies); OR have untreated active hepatitis B, defined as positive for HBsAg with detectable HBV-DNA levels above the upper limit of normal (ULN) as per the central laboratory of the participating study site. 14. Have active hepatitis C virus (HCV) infection, defined as being HCV antibody positive with detectable HCV-RNA levels above the lower limit of detection (LLOD). 15. Have received a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Administration of inactivated, injectable seasonal influenza vaccine within this 30-day period is permitted. However, live attenuated intranasal influenza vaccines are not allowed. 16. Are pregnant or lactating women. 17. Have any severe or uncontrolled systemic diseases. Examples include, but are not limited to: Cardiac disorders: Symptomatic and poorly controlled significant abnormalities in cardiac rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation). Unstable angina, congestive heart failure, or chronic heart failure meeting New York Heart Association (NYHA) Class >= II. Any arterial thromboembolic or ischemic event within 6 months prior to treatment initiation, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. Poorly controlled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg). Pulmonary disorders: History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease. Active pulmonary tuberculosis. Infections: Active or uncontrolled infection requiring systemic therapy. Dermatological/Mucosal disorders: Severe dermatitis or stomatitis. Gastrointestinal disorders: Such as active peptic ulcer, unhealed gastrointestinal perforation or fistula, clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, ulcerative colitis, or other severe digestive diseases. Hepatic disorders: Such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis. Endocrine/Metabolic disorders: Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L). Renal disorders: Urinalysis indicating urine protein >= ++ and confirmed 24-hour urine protein quantification >1.0 g. Other: Patients with psychiatric disorders that would preclude cooperation with treatment, or any electrolyte abnormality considered clinically significant by the investigator. 18. Have any other condition that, in the judgment of the investigator, could lead to premature discontinuation from the study. This may include, but is not limited to, concomitant treatment for other serious diseases, severe laboratory abnormalities, or familial or social circumstances that could compromise the safety of the subject or the collection of data and samples. 19. Have received transfusion therapy, blood products, or hematopoietic growth factors (e.g., albumin, granulocyte colony-stimulating factor [G-CSF]) within 14 days prior to enrollment. 20. Have received brachytherapy (e.g., radioactive seed implantation) within 60 days prior to enrollment.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2029-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-15 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 20

Group：

Experimental Group

Sample size：

干预措施：

索凡替尼联合奥曲肽微球治疗

干预措施代码：

Intervention：

Surufatinib in Combination with Octreotide Microspheres

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院） 

单位级别：

 三级甲等 

Institution
hospital：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存时间（PFS）

指标类型：

主要指标

Outcome：

Progression-Free Survival (PFS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率（ORR）

指标类型：

次要指标

Outcome：

Objective Response Rate (ORR)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病控制率（DCR）

指标类型：

次要指标

Outcome：

Disease Control Rate (DCR)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总生存期（OS）

指标类型：

次要指标

Outcome：

Overall Survival (OS)

Type：

Secondary indicator

测量时间点：

从入组开始到因任何原因导致的死亡的时间间

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例报告表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Crf

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-09 11:51:51